Evidence map›Paper›PMID 25763866›Full record

Trial reportPloS one2015

A randomised, double blind trial of N-Acetylcysteine for hearing protection during stapes surgery.

Dan Bagger-Sjöbäck, Karin Strömbäck, Pierre Hakizimana, Jan Plue, Christina Larsson, Malou Hultcrantz, Georgios Papatziamos, Henrik Smeds, Niklas Danckwardt-Lillieström, Sten Hellström and 3 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00525551 (Acetylcystein Vid Stapedotomi), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00525551 phase4completednot on this map

Acetylcystein Vid Stapedotomi

TypeinterventionalSponsorKarolinska University HospitalRan2007 to 2013Enrolled152ConditionsOtosclerosisArmsAcetylcysteine, Placebo (NaCl)
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Dan Bagger-SjöbäckCenter for Hearing and Communication Research, Department of Clinical Science, Intervention, and Technology, Karolinska Institutet, SE-171 77 Stockholm, Sweden; Department of Otolaryngology, Karolinska University Hospital, SE-171 76 Stockholm, Sweden.
Karin StrömbäckDepartment of Otolaryngology, Academic Hospital, SE-751 85 Uppsala, Sweden.
Pierre HakizimanaCenter for Hearing and Communication Research, Department of Clinical Science, Intervention, and Technology, Karolinska Institutet, SE-171 77 Stockholm, Sweden; Department of Clinical and Experimental Medicine, Linköping University, SE-581 85 Linköping, Sweden.
Jan PlueDepartment of Physical Geography and Quaternary Geology, Stockholm University, SE-106 91 Stockholm, Sweden.
Christina LarssonDepartment of Otolaryngology, Karolinska University Hospital, SE-171 76 Stockholm, Sweden.
Malou HultcrantzCenter for Hearing and Communication Research, Department of Clinical Science, Intervention, and Technology, Karolinska Institutet, SE-171 77 Stockholm, Sweden; Department of Otolaryngology, Karolinska University Hospital, SE-171 76 Stockholm, Sweden.
Georgios PapatziamosDepartment of Otolaryngology, Karolinska University Hospital, SE-171 76 Stockholm, Sweden.
Henrik SmedsCenter for Hearing and Communication Research, Department of Clinical Science, Intervention, and Technology, Karolinska Institutet, SE-171 77 Stockholm, Sweden; Department of Otolaryngology, Karolinska University Hospital, SE-171 76 Stockholm, Sweden.
Niklas Danckwardt-LillieströmDepartment of Otolaryngology, Academic Hospital, SE-751 85 Uppsala, Sweden.
Sten HellströmCenter for Hearing and Communication Research, Department of Clinical Science, Intervention, and Technology, Karolinska Institutet, SE-171 77 Stockholm, Sweden; Department of Audiology and Neurotology, Karolinska University Hospital, SE-171 76 Stockholm, Sweden.
Ann JohanssonDepartment of Audiology and Neurotology, Karolinska University Hospital, SE-171 76 Stockholm, Sweden.
Bo TideholmDepartment of Otolaryngology, Karolinska University Hospital, SE-171 76 Stockholm, Sweden.
Anders FridbergerCenter for Hearing and Communication Research, Department of Clinical Science, Intervention, and Technology, Karolinska Institutet, SE-171 77 Stockholm, Sweden; Department of Clinical and Experimental Medicine, Linköping University, SE-581 85 Linköping, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOtosclerosis is a disorder that impairs middle ear function, leading to conductive hearing loss. Surgical treatment results in large improvement of hearing at low sound frequencies, but high-frequency hearing often suffers. A likely reason for this is that inner ear sensory cells are damaged by surgical trauma and loud sounds generated during the operation. Animal studies have shown that antioxidants such as N-Acetylcysteine can protect the inner ear from noise, surgical trauma, and some ototoxic substances, but it is not known if this works in humans. This trial was performed to determine whether antioxidants improve surgical results at high frequencies.

methodsWe performed a randomized, double-blind and placebo-controlled parallel group clinical trial at three Swedish university clinics. Using block-stratified randomization, 156 adult patients undergoing stapedotomy were assigned to intravenous N-Acetylcysteine (150 mg/kg body weight) or matching placebo (1:1 ratio), starting one hour before surgery. The primary outcome was the hearing threshold at 6 and 8 kHz; secondary outcomes included the severity of tinnitus and vertigo.

findingsOne year after surgery, high-frequency hearing had improved 2.7 ± 3.8 dB in the placebo group (67 patients analysed) and 2.4 ± 3.7 dB in the treated group (72 patients; means ± 95% confidence interval, p = 0.54; linear mixed model). Surgery improved tinnitus, but there was no significant intergroup difference. Post-operative balance disturbance was common but improved during the first year, without significant difference between groups. Four patients receiving N-Acetylcysteine experienced mild side effects such as nausea and vomiting.

conclusionsN-Acetylcysteine has no effect on hearing thresholds, tinnitus, or balance disturbance after stapedotomy.

trial registrationClinicalTrials.gov NCT00525551.

Indexed as

AcetylcysteineAdministration, IntravenousAntioxidantsAudiometry, Pure-ToneDouble-Blind MethodFemaleHumansMaleMiddle AgedOtologic Surgical ProceduresOtosclerosisStapes SurgeryTinnitusTreatment OutcomeVertigoAcetylcysteineAntioxidants

Identifiers

PMID25763866
PMCPMC4357436

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.